(SLB-028) Utilization of Statins and other Lipid-Modifying Agents During Pregnancy in the US, 2005-2021

Background: The US FDA removed the contraindication for statin use in pregnancies at high risk for cardiovascular events in July 2021; it is unclear how this has affected real-world treatment patterns for pregnant women with dyslipidemia.

Objectives: To describe the utilization patterns of statins and other lipid-modifying agents (LMA) before, during, and after pregnancy in the US from 2005 to 2021.

Methods: This retrospective study used MarketScan® commercial claims data from 2005 to 2022. We used a validated algorithm to identify pregnancies resulting in live births among individuals aged 18 to 55 years who had continuous healthcare enrollment from 90 days before conception through 90 days after the end of pregnancy. LMA exposure was defined as ≥1 prescription fill during each of the following pregnancy periods: baseline (90 days before conception), first trimester (T1, conception to 75 days post-conception), second trimester (T2, 76 to 165 days post-conception), third trimester (T3, 166 days post-conception to delivery), and postpartum (90 days after delivery).

Results: We included a total of 2,888,451 live-birth pregnancies conceived during 2005-2021. Among them, 4,341 (1.5 per 1,000) had statin dispensing, and 44,560 (15.4 per 1,000) had non-statin LMA dispensing. Statin use declined throughout pregnancy, from 6,933 (2.4 per 1,000) at baseline to 3,466 (1.2 per 1,000) in T1, 1,764 (0.61 per 1,000) in T2, 1,655 (0.57 per 1,000) in T3, and increased to 4,479 (1.55 per 1,000) in the postpartum period. The average maternal age for women with an LMA during pregnancy (T1-T3) was 32.4 years. Women who continued statin during pregnancy had higher maternal age than those who discontinued (38.1 vs. 34.3 yrs). During the study period, three-quarters of the statins used during pregnancy were lipophilic, but their proportion declined from 86% in 2005 to 58% in 2021. Atorvastatin and simvastatin were the most frequent statin choices before, during, and after pregnancy. In 2021, the prevalence of statin during pregnancy was 1.2 per 1,000 in the first two quarters, increasing slightly to 1.3 per 1,000 in the subsequent quarters, similar to the earliest quarters in the study period (1.3, 1.3, and 1.5 per 1,000 in Q2, Q3, and Q4 of 2005, respectively). However, statin discontinuation between baseline and T3 was higher in 2021 (84.7% in Q3, 83.3% in Q4) compared to 2005 (74.6% in Q3, 70.9% in Q4).

Conclusions: The use of statins during pregnancy remained stable throughout the study period, with no immediate change following the FDA’s removal of the pregnancy contraindication in July 2021. Our follow-up study will examine the impact of the FDA’s labeling change as more data becomes available.